European and North Indian Cohort of KaWasaki dIsease

Recruiting

• Conditions: Kawasaki Disease

• Registration Number: NCT06305611
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief Summary

Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-13
• Study First Submitted: 2024-02-16
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-07-15
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Patients aged less than 18 years at diagnosis
• Diagnosis of KD according to the AHA criteria

Exclusion Criteria

• Patients who do not meet the criteria for KD
• Patients for which an alternative infectious diagnosis was not investigated and/or excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IVIG resistance rate	through study completion, an average of 1 year	IVIG resistance rate in patients with KD and stratification according to different ethnic groups.
percentage of IVIG-resistant patients	through study completion, an average of 1 year	percentage of IVIG-resistant patients who met the Kobayashi and KAWANET criteria, and specificity and sensitivity of the criteria within the different ethnic groups.

Trial Locations

Locations (27)

University Hospital Centre Zagreb, University School of Medicine; 🇭🇷 Zagreb, Croatia

Manipal Hospital; 🇮🇳 Bangalore, India

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India

Institute of Child Health; 🇮🇳 Kolkata, India

Children's Hospital Zagreb; 🇭🇷 Zagreb, Croatia

Amrita Institute of Medical Sciences; 🇮🇳 Kochi, India

Vivekananda Institute of Medical Sciences; 🇮🇳 Kolkata, India

Beatrix Kinderkliniek, University Medical Center; 🇳🇱 Groningen, Netherlands

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

P.O. "Giovanni Di Cristina"; 🇮🇹 Palermo, Italy

Università di Torino; 🇮🇹 Torino, Italy

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil

Sri Ramachandra Medical Centre; 🇮🇳 Chennai, India

Le Kremlin-Bicetre University Hospital, Paris-Sud University - CEREMAI; 🇫🇷 Le Kremlin-Bicêtre, France

Meir Medical Centre; 🇮🇱 Kfar Saba, Israel

ASST Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy

IRCCS Istituto Giannina Gaslini; 🇮🇹 Genova, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

IRCCS Burlo Garofolo; 🇮🇹 Trieste, Italy

Hospital de Sabadell; 🇪🇸 Barcellona, Spain

Hospital Sant Joan de Déu; 🇪🇸 Barcellona, Spain

Health Sciences University, Umraniye Education and Research Hospital; 🇹🇷 Istanbul, Turkey

Chiang Mai University Hospital; 🇹🇭 Chiang Mai, Thailand

Hacettepe University Children's Hospital; 🇹🇷 Ankara, Turkey

Royal Hospital for Children; 🇬🇧 Bristol, United Kingdom

Istanbul Uni. Istanbul Med.Fac; 🇹🇷 Istanbul, Turkey